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Feb 04, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Ravicti glycerol phenylbutyrate regulatory update

FDA approved an NDA for Ravicti glycerol phenylbutyrate from Hyperion for the management of chronic urea cycle disorders in patients >=2 years of age. The company said it plans to launch the drug in April, but did not disclose a price for the pre-prodrug of phenylacetic acid.

In January, FDA told...

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